K040599 is an FDA 510(k) clearance for the PARKELL RESIN GLAZE. This device is classified as a Coating, Filling Material, Resin (Class II - Special Controls, product code EBD).
Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on April 9, 2004, 32 days after receiving the submission on March 8, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3310.
| 510(k) Number | K040599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2004 |
| Decision Date | April 09, 2004 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBD — Coating, Filling Material, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3310 |